K261535
- 510(k) number
- K261535
- Device name
- Hi-D Imaging 4TAVR
- Applicant
- Hi-D Imaging AG CH
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-07-20
- Date received
- 2026-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K261535.pdf
Official FDA record: K261535
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.